Oxytek Medical Technology Co., Ltd. is pleased to announce that its OX-1B and OX-1A-E portable oxygen concentrators have successfully obtained CE certification under the European Union Medical Device Regulation (EU MDR 2017/745), following the applicable conformity assessment process conducted by DNV.

This achievement represents another important milestone in Oxytek’s commitment to international regulatory compliance and further strengthens the company’s portfolio of portable oxygen therapy solutions for global markets.

Meeting the Requirements of the EU MDR

The EU Medical Device Regulation (MDR) has established more comprehensive requirements for medical device manufacturers, covering areas including product safety, clinical evaluation, quality management, technical documentation, and post-market surveillance.

The successful MDR certification of the OX-1B and OX-1A-E demonstrates Oxytek’s continued investment in product quality, regulatory compliance, and the development of medical devices designed for international markets.

For European distributors, homecare providers, DME companies, and oxygen therapy brands, the certification provides an important regulatory foundation for cooperation involving these two portable oxygen concentrators.

OX-1B: Designed for Portability and Serviceability

The OX-1B is a lightweight portable oxygen concentrator designed to provide greater flexibility for users requiring oxygen therapy in their daily lives.

Weighing approximately 2.2 kg, the OX-1B provides six oxygen delivery settings in a compact form factor.

The device also incorporates a service-oriented design, including a removable battery and replaceable oxygen-generation system. These features are intended to provide greater flexibility for maintenance and after-sales service, particularly for professional distributors and service providers.

By combining portability with a practical serviceability concept, the OX-1B is designed to support the needs of both end users and professional oxygen therapy providers.

OX-1A-E: A Compact Portable Oxygen Solution

The OX-1A-E is a lightweight portable oxygen concentrator developed for users seeking a compact and convenient oxygen therapy solution.

The device features six oxygen delivery settings and provides a maximum oxygen output of up to 1,200 mL/min, offering flexibility for different portable oxygen therapy requirements.

Its compact design and lightweight construction make the OX-1A-E suitable for a variety of homecare and portable oxygen therapy applications.

Expanding Oxytek’s European Market Opportunities

With the addition of the OX-1B and OX-1A-E, Oxytek continues to expand its portfolio of oxygen concentrators certified under the EU MDR.

The two portable models complement Oxytek’s existing stationary oxygen concentrator portfolio and provide international partners with additional options for developing their portable oxygen therapy businesses.

The MDR certification also supports Oxytek’s cooperation with:

• European medical device distributors

• Homecare and DME providers

• Oxygen therapy companies

• Medical equipment brands

• OEM and private-label partners

• Rental and service providers

Oxytek will continue to work closely with its international partners to provide regulatory-compliant oxygen therapy products and support the development of long-term cooperation in the European market.

Continuing Our Commitment to Quality and Innovation

Obtaining EU MDR CE certification is an important step in Oxytek’s ongoing development as an international oxygen concentrator manufacturer.

Oxytek will continue to invest in product development, quality management, regulatory compliance, and after-sales support, with the goal of providing reliable oxygen therapy solutions for customers and partners worldwide.

With the OX-1B and OX-1A-E now certified under the EU MDR, Oxytek looks forward to bringing its latest portable oxygen concentrator solutions to more European and international markets.

About Oxytek Medical Technology

Oxytek Medical Technology Co., Ltd. specializes in the development and manufacturing of oxygen concentrators, with a product portfolio covering portable and stationary oxygen therapy solutions.

The company works with distributors, homecare providers, healthcare companies, and oxygen therapy brands across international markets.

Oxytek is committed to developing reliable oxygen therapy products supported by continuous innovation, quality management, and international regulatory compliance.